The present invention is related, generally, to the field of medicine delivery apparatuses, systems and methods. More specifically, embodiments of the present invention are related to articles, systems, and methods that are used in the preparation and administration of intravenous (“IV”) medications to patients, via IV devices, particularly via an IV Bag Container. Through its one piece self-contained design, the invention significantly prevents or completely eliminates three major health and safety issues plaguing the health care industry in connection with the preparation and administration of IV solutions containing medication: sharps injuries, medically administered errors (“MAE's), and exposure to hazardous medications by the health care professional.
Additionally, the designs of the invention allow a user to control the reconstitution of a medication and also control in metered dosage the medication to be introduced to an IV device solution without the use of any other component or apparatus.
The World Health Organization has estimated the global disease burden from contaminated sharps injuries suffered by health-care workers at the workplace by analyzing 25 risk factors that covered occupation, environment, lifestyle, diet, health practices and substance abuse (WHO, 2002). In this study, only percutaneous exposures (i.e., sharps injuries) were considered because such exposures were associated with the highest risk of transmission and they accounted for the largest proportion of reported exposures. In Canada, Italy, Spain and the United States of America, for example, percutaneous exposures accounted for 66%-95% of all occupational exposures to blood borne pathogens and, of these, needle-stick injuries accounted for 62%-91% (Romea et al., 1995; EPINet, 1998; NaSH, 1999; CCOHS, 2000; Puro et al., 2001). It is estimated that 600,000 to 800,000 needlestick injuries occur per year. These injuries occur from the time the syringe and needle is prepared through its disposal.
There have been numerous reports analyzing the exposure of medical and non-medical staff to hazardous medications. Health Care Professionals and other non-medical staff have numerous opportunities to come in contact with hazardous drugs. Contact can occur during preparation, administration or waste disposal. Accidental injection, inhalation and dermal contact are the primary contributors of exposure to hazardous drugs. Exposure to these drugs has been associated with acute and short term reactions as well as long-term effects. Case reports include skin-related and ocular effects as well as flu-like symptoms and headache. Reproductive studies on health care workers have shown an increase in fetal abnormalities, fetal loss, and fertility impairment. There has also been some indication of increased cases of cancer in healthcare workers exposed to hazardous medications (American Society of Health System Pharmacists. See ASHP guidelines on handling hazardous drugs (Am. J. Health-Syst. Pharm. 2006; 63:1172-93).
Additional studies highlight the critical importance of properly reconstituting a medication and, as such, the manufacturers PI (packet insert) and approved method for the reconstitution should not be altered. For instance, most lyophilized medications require exact measurements of a specific diluent, and some manufacturers require the reconstitution to take place over a period of time to avoid a variety of issues including, incomplete reconstitution, foaming among others. Current commercialized single unit IV bag devices that allow for the transfer of a medication from a Vial to a IV bag offer limited or no control for the reconstitution of a medication.
The disclosed invention allows for an exact amount of diluent to be introduced one or more times and/or over a period of time into the Vial according to manufacturer's approved method to obtain a properly reconstituted solution of the medication.
Furthermore, the disclosed invention allows for the properly reconstituted medication to be controlled during the introduction of the medication to the IV bag's solution by specific metered doses pursuant to the manufacturers' and/or other patient or medication characteristic or demand. This controlled dosing may take place during the preparation and/or during the administration period allowing accurate dosing and/or adjustments for increased strengths of the solution. Current known commercialized products do not allow for controlled reconstitution or metered dosage of the medication.